BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEFLON PLEDGETS UNKNOWN PRODUCT

    MDR report key: 10766691 · Received October 30, 2020

    Report

    Report Number
    2210968-2020-08512
    Event Type
    Death
    Date Received
    October 30, 2020
    Date of Event
    January 1, 2019
    Report Date
    October 9, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    DXZ
    PMA / PMN Number
    K811872
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (PLEDGETED PROLENE SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (BLEEDING, RECURRENT PVE) DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED (PLEDGETED PROLENE SUTURE) CAUSED AND/OR CONTRIBUTED TO PATIENT DEATH FROM EARLY RECURRENT PVE DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (PLEDGETED PROLENE SUTURE) USED IN THIS PROCEDURE? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PRODUCT CODE FOR THE PLEDGETED PROLENE SUTURE. PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED BLEEDING, PATIENT DEMOGRAPHICS FOR THE PATIENT THAT EXPIRED FROM EARLY RECURRENT PVE. CITATION: ANN THORAC SURG 2019;108:E213-5. DOI: HTTPS://DOI.ORG/10.1016/J.ATHORACSUR.2019.03.068. NOTE: EVENTS REPORTED VIA MW #2210968-2020-08511. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: THE MITRAL MONOBLOC: A SIMPLIFICATION FOR INTERVALVULAR FIBROUS BODY RECONSTRUCTION IN ENDOCARDITIS". AUTHORS: JOSHUA L. HERMSEN, MD, ENTELA B. LUSHAJ, MD, PHD, AND NILTO C. DE OLIVEIRA, MD. CITATION: ANN THORAC SURG 2019;108:E213-5. DOI: HTTPS://DOI.ORG/10.1016/J.ATHORACSUR.2019.03.068. THE ONLY VIABLE OPTION IN PROSTHETIC VALVE ENDOCARDITIS WITH EXTENSIVE ABSCESS OF THE AORTO-MITRAL CURTAIN IS RADICAL DEBRIDEMENT AND RECONSTRUCTION OF THE INTERVALVULAR FIBROUS BODY. THIS REPORT DETAILS A SIMPLIFIED INTERVALVULAR FIBROUS BODY RECONSTRUCTION TECHNIQUE. THIS RETROSPECTIVE STUDY INVOLVES 6 CONSECUTIVE PATIENTS REQUIRING URGENT RE-OPERATIONS FOR PROSTHETIC VALVE ENDOCARDITIS (PVE) INVOLVING THE AORTO-MITRAL CURTAIN FROM 2008 TO 2019. DURING THE PROCEDURE, A 3-0 PLEDGETED PROLENE (ETHICON, (B)(6)) SUTURE WAS PLACED THROUGH THE CUT EDGE OF THE FIBROUS BODY ON EITHER SIDE AND BROUGHT THROUGH THE MONOBLOC CUFF JUST UNDERNEATH THE FOLD. THIS SUTURE IS THEN USED TO RUN THE PATCH TO THE AORTA ON EITHER SIDE. AN AORTIC VALVE PROSTHESIS APPROPRIATELY SIZED TO THE NEOAORTIC ANNULUS IS CHOSEN AND IMPLANTED WITH A PLEDGETED MATTRESS SUTURE TECHNIQUE . POSTERIORLY, THE SUTURES ARE BROUGHT FROM OUTSIDE IN THROUGH THE PATCH AT A LEVEL 1 OR 2 CORRUGATIONS ABOVE THE FOLD . THE JUNCTION OF THE MONOBLOC AND NATIVE ANNULUS ON EITHER SIDE IS SPANNED WITHIN 1 OF THESE VALVE SUTURES. THE FOLD PROVIDES A FREE EDGE THAT AIDS IN CLOSURE OF THE ROOF OF THE LEFT ATRIUM AS OPPOSED TO ANCHORING DIRECTLY TO THE SEWING RING OF THE VALVE REPORTED COMPLICATIONS INCLUDED BLEEDING (N-1) IN WHICH THE PATIENT WAS REEXPLORED, AND RECURRENT PVE (N-1). ONE PATIENT DEVELOPED EARLY RECURRENT PVE AND DIED. THE MITRAL ¿HEMI-BLOC¿ TECHNIQUE DESCRIBED IN THIS PAPER SIMPLIFIES A COMPLEX, POTENTIALLY CURATIVE REPAIR INEVITABLY BEING CARRIED OUT IN A SICK PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231291 TEFLON PLEDGETS UNKNOWN PRODUCT PATCH, PLEDGET AND INTRACARDIAC DXZ ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death